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Review Article

High-Performance Liquid Chromatography Methods for Determining the Purity of Drugs with Weak UV Chromophores – A Review

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References

  • ICH Harmonised Tripartite Guideline, Impurities in new drug substances Q3A(R2). https://database.ich.org/sites/default/files/Q3A%28R2%29%20Guideline.pdf (accessed Jul 27, 2023).
  • ICH Harmonised Tripartite Guideline, Impurities in new drug products Q3B(R2). https://database.ich.org/sites/default/files/Q3B%28R2%29%20Guideline.pdf (accessed Jul 27, 2023).
  • Siddiqui, M. R.; Al Othman, Z. A.; Rahman, R. Analytical Techniques in Pharmaceutical Analysis: A Review. Arab. J. Chem. 2017, 10, S1409–S1421. DOI: 10.1016/j.arabjc.2013.04.016.
  • ICH Harmonised Tripartite Guideline, Specifications. test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances Q6A, https://database.ich.org/sites/default/files/Q6A%20Guideline.pdf (accessed Jul. 27, 2023).
  • Sunil, A.; Anju, G.; Rajat, V. HPLC Detectors, Their Types and Use: A Review. Organ. Med. Chem IJ 2018, 6, 143–146. DOI: 10.19080/OMCIJ.2018.06.555700.
  • Vidushi, Y.; Meenakshi, B. A Review on HPLC Method Development and Validation. Res. J. Life Sci. Bioinform. Pharma. Chem. Sci. 2017, 2, 166–175. DOI: 10.26479/2017.0206.12.
  • ICH Harmonised Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology Q2(R1). https://database.ich.org/sites/default/files/Q2%28R1%29%20Guideline.pdf (accessed Jul. 27, 2023).
  • Yuabova, Z. Y.; Holschlag, D. R.; Rodriguez, S. A.; Qin, C.; Papov, V. V.; Qiu, F.; McCaffrey, J. F.; Norwood, D. L. Genotoxic Impurities: A Quantitative Approach. J. Liq. Chromatogr. Relat. Technol., 2008, 31, 2318–2330. DOI: 10.1080/10826070802281745.
  • Cintrón, J. M.; Risley, D. S. Hydrophilic Interaction Chromatography with Aerosol-Based Detectors (ELSD, CAD, NQAD) for Polar Compounds Lacking a UV Chromophore in an Intravenous Formulation. J. Pharm. Biomed. Anal. 2013, 78-79, 14–18. DOI: 10.1016/j.jpba.2013.01.022.
  • Gamache, P. H.; McCarthy, R. S. Freeto, M. S. HPLC Analysis of Non-Volatile Analytes Using Charged Aerosol Detection. LC GC Europe 2005, 18, 345–354.
  • Wolfender, J. L. HPLC in Natural Product Analysis: The Detection Issue. Planta Med. 2009, 75, 719–734. DOI: 10.1055/s-0028-1088393.
  • Magnusson, L. E.; Risley, D. S.; Koropchak, J. A. Aerosol-Based Detectors for Liquid Chromatography. J. Chromatogr. A 2015, 1421, 68–81. DOI: 10.1016/j.chroma.2015.07.045.
  • Megoulas, N. C.; Koupparis, M. A. Development and Validation of a Novel HPLC/ELSD Method for the Direct Determination of Tobramycin in Pharmaceuticals, Plasma, and Urine. Anal. Bioanal. Chem. 2005, 382, 290–296. DOI: 10.1007/s00216-004-2948-8.
  • Zhu, L.; Wang, J. Fast Determination of Tobramycin by Reversed-Phase Ion-Pair High Performance Liquid Chromatography with a Refractive Index Detector. Front. Chem. Sci. Eng. 2013, 7, 322–328. DOI: 10.1007/s11705-013-1348-z.
  • Setiawati, H.; Harmita, H.; Suryadi, H. Development and Validation Method for Simultaneous Quantification of Neomycin and Polymyxin B by HPLC-ELSD and Comparison with Microbiological Method. J. Appl. Pharma. Sci. 2020, 10, 129–134.
  • Jiang, Y.; Xie, Z. Determination of Ibandronate and Its Degradation Products by Ion-Pair RP LC with Evaporative Light-Scattering Detection. Chroma. 2005, 62, 257–261. DOI: 10.1365/s10337-005-0618-4.
  • Li, H.; Yang, Z.; Wang, J.; An, Y.; Wang, C.; Guo, X.; Wang, Y. Chemical Fingerprint for Identification and Quality Control of Saccharides in Danhong Injection Based on HPLC-ELSD with Chemometrics. Chem. Res. Chin. Univ. 2019, 35, 782–787. DOI: 10.1007/s40242-019-9030-8.
  • Burmaoglu, R. E.; Aslan, S. S. Determination of Zoledronic Acid and Its Related Substances by High Performance Liquid Chromatography with Evaporative Light Scattering Detection. J. Chromatogr. Sci. 2019, 57,1, 33–43.
  • Clarot, I.; Regazzeti, A.; Auzeil, N.; Laadani, F.; Citton, M.; Netter, P.; Nicolas, A. Analysis of Neomycin Sulfate and Framycetin Sulfate by High-Performance Liquid Chromatography Using Evaporative Light Scattering Detection. J. Chromatogr. A 2005, 1087, 236–244. DOI: 10.1016/j.chroma.2005.05.054.
  • Eom, H. Y.; Park, S.-Y.; Kim, M. K.; Suh, J. H.; Yeom, H.; Min, J. W.; Kim, U.; Lee, J.; Youm, J.-R.; Han, S. B. Comparison between Evaporative Light Scattering Detection and Charged Aerosol Detection for the Analysis of Saikosaponins. J. Chromatogr. A 2010, 1217, 4347–4354. DOI: 10.1016/j.chroma.2010.04.047.
  • Chopra, S.; Vanderheyden, G.; Hoogmartens, J.; Schepdael, A. V.; Adams, E. Comparative Study on the Analytical Performance of Different Detectors for the Liquid Chromatographic Analysis of Tobramycin. J. Pharm. Biomed. Anal. 2010, 53, 151–157. DOI: 10.1016/j.jpba.2010.02.032.
  • Wang, J.; Hu, X.; Tu, Y.; Ni, K. Determination of Spectinomycin Hydrochloride and Its Related Substances by HPLC–ELSD and HPLC–MS. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 2006, 834, 178–182. DOI: 10.1016/j.jchromb.2006.02.045.
  • Liu, X.-K.; Fang, J. B.; Cauchon, N.; Zhou, P. Direct Stability-Indicating Method Development and Validation for Analysis of Etidronate Disodium Using a Mixed-Mode Column and Charged Aerosol Detector. J. Pharm. Biomed. Anal. 2008, 46, 639–644. DOI: 10.1016/j.jpba.2007.11.041.
  • Ilko, D.; Puhl, S.; Meinel, L.; Germershaus, O.; Holzgrabe, U. Simple, and Rapid High Performance Liquid Chromatography Method for the Determination of Polidocanol as Bulk Product and in Pharmaceutical Polymer Matrices Using Charged Aerosol Detection. J. Pharm. Biomed. Anal. 2015, 104, 17–20. DOI: 10.1016/j.jpba.2014.11.012.
  • Huang, Y.; Lu, H.; Li, Z.; Zeng, Y.; Xu, Q.; Wu, Y. Development of HPLC-CAD Method for Simultaneous Quantification of Nine Related Substances in Ursodeoxycholic Acid and Identification of Two Unknown Impurities by HPLC-Q-TOF-MS. J. Pharm. Biomed. Anal. 2023, 229, 115357. DOI: 10.1016/j.jpba.2023.115357.
  • Prudhviraju, C. H.; Swaminathan, J.; Nataraj, K. S.; Rajasekhar, B. Pre and Post Column Derivatization of Amino Acid - A Systematic Review of HPLC. Act. Scie. Pharma. 2021, 5, 104–115. DOI: 10.31080/ASPS.2021.05.0773.
  • Gatti, R.; Lotti, C. Development and Validation of a Pre-Column Reversed Phase Liquid Chromatographic Method with Fluorescence Detection for the Determination of Primary Phenethylamines in Dietary Supplements and Phytoextracts. J. Chromatogr. A 2011, 1218, 4468–4473. DOI: 10.1016/j.chroma.2011.05.044.
  • Adegoke, O. A. An Overview of Applications of Pre-Column Derivatization Reactions for the Liquid Chromatographic Analysis of Pharmaceuticals and Other Compounds. Afr. J. Pure Appl. Chem. 2012, 6, 129–140.
  • Gottschalk, M.; Pickering, M. An Overview of Post Column Derivatization Methods from a Pharmaceutical Applications Perspective, Pickering Laboratories, https://www.pickeringlabs.com/wp-content/uploads/2015/01/Pharmaceutical-Post-Column-Derivatization.pdf.
  • Cardinael, P.; Casabianca, H.; Peulon-Agasse, V. Berthod, A. Sample Derivatization in Separation Science. Anal. Sep. Sci. Wiley-Ch, 2015, 5, 1725–1755.
  • Yun, M.-H.; Kwon, K. High-Performance Liquid Chromatography Method for Determining Alendronate Sodium in Human Plasma by Detecting Fluorescence: Application to a Pharmacokinetic Study in Humans. J. Pharm. Biomed. Anal. 2006, 40, 168–172. DOI: 10.1016/j.jpba.2005.06.025.
  • Zhang, L.-J.; Huang, T.-M.; Fang, X-l.; Li, Z.-N.; Wang, Q.-S.; Zhang, Z.-W.; Sha, X.-Y. Determination of Glucosamine Sulfate in Human Plasma by Precolumn Derivatization Using High Performance Liquid Chromatography with Fluorescence Detection: Its Application to a Bioequivalence Study. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 2006, 842, 8–12. DOI: 10.1016/j.jchromb.2006.04.045.
  • Douša, M.; Břicháč, J.; Tkadlecová, M.; Man, S.; Zezula, J.; Hájíček, J.; Pekárek, T. A Novel Approach for HPLC Determination of 2-Cynaoacetamide Using Derivatization Procedure with 2-Hydroxyacetophenone as a New Useful Derivatization Reagent. J. Pharm. Biomed. Anal. 2016, 128, 391–397. DOI: 10.1016/j.jpba.2016.06.016.
  • Kowalczuk, D.; Pietraś, R.; Paw, B.; Czerkies, A. Applying Liquid Chromatography with Fluorescence Detection to Determine Gentamicin. Pol. J. Environ. Stud. 2010, 19, 587–591.
  • Martinc, B.; Roškar, R.; Grabnar, I.; Vovk, T. Simultaneous Determination of Gabapentin, Pregabalin, Vigabatrin, and Topiramate in Plasma by HPLC with Fluorescence Detection. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 2014, 962, 82–88. DOI: 10.1016/j.jchromb.2014.05.030.
  • Haque, S. M.; Ratemi, E. S. Drug Development and Analysis Review. Pharm. Chem. J. 2017, 50, 837–850. DOI: 10.1007/s11094-017-1543-1.
  • Blanchaert, B.; Poderós Jorge, E.; Jankovics, P.; Adams, E.; Van Schepdael, A. Assay of Kanamycin a by HPLC with Direct UV Detection. Chromatographia 2013, 76, 1505–1512. DOI: 10.1007/s10337-013-2440-8.
  • Alzweiri, M.; Al-Hiari, Y. M.; Aburjai, T. On-Column Approach in the HPLC-UV Analysis of Non-Chromophoric Compounds Using Azelaic Acid as a Model. Jordan J. Pharm. Sci. 2012, 5, 243–250.
  • Ashfaq, M.; Aslam, A.; Mustafa, G.; Danish, M.; Nazar, M. F.; Asghar, M. N. Derivatization/Chromophore Introduction of Tranexamic Acid and Its HPLC Determination in Pharmaceutical Formulations. J. Assoc. Arab Univ. Basic Appl. Sci. 2015, 17, 51–56. DOI: 10.1016/j.jaubas.2014.02.005.
  • Castellanos, M.; Fernández-Couto, D.; Da Silva-Candal, A.; Feal-Painceiras, M. J.; Rodríguez-Yáñez, M.; Gubern-Mérida, C.; Sanchez, J. M. Liquid Chromatography Fingerprint Analysis of Released Compounds in Plasma Samples of Stroke Patients after Thrombolytic Treatment. Separations 2023, 10, 34. DOI: 10.3390/separations10010034.
  • Abualhasan, M.; Shraim, F.; Alawni, H.; Hamdan, S.; Khaseeb, H. HPLC Analytical Method Development and Validation of Gabapentin through Chemical Derivatization with Catechol as a Chromophore. Int. J. Anal. Chem. 2022, 2022, 3882682–3882688. DOI: 10.1155/2022/3882682.
  • Anjani, Q. K.; Bin Sabri, A. H.; Donnelly, R. F. Development and Validation of Simple and Sensitive HPLC-UV Method for Ethambutol Hydrochloride Detection following Transdermal Application. Anal. Methods 2022, 14, 125–134. DOI: 10.1039/d1ay01414e.
  • Abdel-Gawad, S. A.; Arab, H. H. Sensitive and Accurate Method for Chromatographic Quantification of Ibandronate in Bulk and Dosage Forms. Trop. J. Pharm. Res. 2022, 21, 137–141.
  • Shen, X.; Yang, M.; Tomellini, S. A. Liquid Chromatographic Analysis of Glucosamine in Commercial Dietary Supplements Using Indirect Fluorescence Detection. J. Chromatogr. Sci. 2007, 45, 70–75. DOI: 10.1093/chromsci/45.2.70.
  • Swartz, M. HPLC Detectors: A Brief Review. J. Liq. Chromatogr. Relat. Technol. 2010, 33, 1130–1150. DOI: 10.1080/10826076.2010.484356.
  • Gamal, M.; Abd Elhalim, L. M. Novel Eco-Friendly HPLC Methods Using Refractive Index Detector for Analysis of Three Veterinary Antibiotics in Pharmaceutical Formulations and Rat Plasma. J. Chromatogr. Sci. 2020, 58, 940–950. DOI: 10.1093/chromsci/bmaa065.
  • Kulkarni, S.; Sawant, A.; Zinjad, P.; Sanatan, P.; Bhope, S.; Padmanabhan, S. Development and Validation of Green Chemistry HPLC-RI Method for the Simultaneous Estimation of Glucosamine and Chondroitin Sulfate from Drug Products. JABB. 2022, 9, 67–74. DOI: 10.15406/jabb.2022.09.00287.
  • Abid, F.; Youssef, S. H.; Song, Y.; Parikh, A.; Trott, D.; Page, S.; Garg, S. Development and Validation of a New Analytical Method for Estimation of Narasin Using Refractive Index Detector and Its Greenness Evaluation. Microchem. J. 2022, 175, 107149. DOI: 10.1016/j.microc.2021.107149.
  • Sunil, A.; Anju, G.; Rajat, V. HPLC Detectors, Their Types and Use: A Review. Org. Med. Chem. 2018, 6, 5.
  • Pujol-Brugués, A.; Calpena-Campmany, A. C.; Riera-Lizandra, C.; Halbaut-Bellowa, L.; Clares-Naveros, B. Development of a Liquid Chromatographic Method for the Quantification of Paromomycin. Application to in Vitro Release and Ex Vivo Permeation Studies. Spectrochim. Acta. A Mol. Biomol. Spectrosc. 2014, 133, 657–662. DOI: 10.1016/j.saa.2014.06.017.
  • Lee, S.-M.; Jeong, J.-S.; Kwon, H.-J.; Hong, S.-P. Quantification of Isoflavonoids and Triterpene Saponins in Astragali Radix, the Root of Astragalus Membranaceus, via Reverse-Phase High-Performance Liquid Chromatography Coupled with Integrated Pulsed Amperometric Detection. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 2017, 1070, 76–81. DOI: 10.1016/j.jchromb.2017.10.046.
  • Hsieh, Y. HPLC-MS/MS in Drug Metabolism and Pharmacokinetic Screening. Expert Opin. Drug Metab. Toxicol. 2008, 4, 93–101. DOI: 10.1517/17425255.4.1.93.
  • Bhateria, M.; Ramakrishna, R.; Pakala, D. B.; Bhatta, R. S. Development of an LC–MS/MS Method for Simultaneous Determination of Memantine and Donepezil in Rat Plasma and Its Application to Pharmacokinetic Study. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 2015, 1001, 131–139. DOI: 10.1016/j.jchromb.2015.07.042.
  • Xiang, X.; Ko, C.; Guh, H. Y. Ion-Exchange Chromatography/Electrospray Mass Spectrometry for the Identification of Organic and Inorganic Species in Topiramate Tablets. Anal. Chem. 1996, 68, 3726–3731. DOI: 10.1021/ac960425x.
  • Zhang, B.; Li, X.; Yan, B. Advances in HPLC Detection—towards Universal Detection. Anal. Bioanal. Chem. 2008, 390, 299–301. DOI: 10.1007/s00216-007-1633-0.
  • Schilling, K.; Holzgrabe, U. Recent Applications of the Charged Aerosol Detector for Liquid Chromatography in Drug Quality Control. J. Chromatogr. A 2020, 1619, 460911. DOI: 10.1016/j.chroma.2020.460911.
  • Pinto, E. C.; Dolzan, M. D.; Cabral, L. M.; Armstrong, D. W.; de Sousa, V. P. Topiramate: A Review of Analytical Approaches for the Drug Substance, Its Impurities and Pharmaceutical Formulations. J. Chromatogr. Sci. 2016, 54, 280–290. DOI: 10.1093/chromsci/bmv120.
  • Bahrami, G.; Mirzaeei, S.; Mohammadi, B.; Kiani, A. High Performance Liquid Chromatographic Determination of Topiramate in Human Serum Using UV Detection. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 2005, 822, 322–325. DOI: 10.1016/j.jchromb.2005.05.032.
  • Bahrami, G.; Mohammadi, B. A Novel High Sensitivity HPLC Assay for Topiramate, Using 4-Chloro-7-Nitrobenzofurazan as Pre-Column Fluorescence Derivatizing Agent. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 2007, 850, 400–404. DOI: 10.1016/j.jchromb.2006.12.016.
  • Milosheska, D.; Roškar, R. A Novel LC–MS/MS Method for the Simultaneous Quantification of Topiramate and Its Main Metabolites in Human Plasma. J. Pharm. Biomed. Anal. 2017, 138, 180–188. DOI: 10.1016/j.jpba.2017.02.003.
  • Biró, A.; Pergel, É.; Árvai, G.; Ilisz, I.; Szepesi, G.; Péter, A.; Lukács, F. High-Performance Liquid Chromatographic Study of Topiramate and Its Impurities. Chroma. 2006, 63, S137–S141. DOI: 10.1365/s10337-006-0818-6.
  • Pinto, E. C.; Gonçalves, M. d S.; Cabral, L. M.; Armstrong, D. W.; de Sousa, V. P. Development and Validation of a Stability-Indicating HPLC Method for Topiramate Using a Mixed-Mode Column and Charged Aerosol Detector. J. Sep. Sci. 2018, 41, 1716–1725. DOI: 10.1002/jssc.201701340.
  • Liang, X.; Patel, H.; Young, J.; Shah, P.; Raglione, T. The Practical Application of Implementing the Equimolar Response Principle of Chemiluminescent Nitrogen Detection in Pharmaceutical Analysis. J. Pharm. Biomed. Anal. 2008, 47, 723–730. DOI: 10.1016/j.jpba.2008.02.026.
  • Styslo-Zalasik, M.; Li, W. Determination of Topiramate and Its Degradation Product in Liquid Oral Solutions by High Performance Liquid Chromatography with a Chemiluminescent Nitrogen Detector. J. Pharm. Biomed. Anal. 2005, 37, 529–534. DOI: 10.1016/j.jpba.2004.11.010.

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